FDA.reportPublic FDA data

SK PODO 0.394 in (10 mm) round orange - medium

Primary DI
04027497276639
Brand
SK PODO 0.394 in (10 mm) round orange - medium
Company
LUKAS-ERZETT GmbH & Co. KG
Model
A611001021500061
Catalog number
A611001021500061
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GFFBur, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14027497276636PrimaryGS10
04027497276639Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1402749727663614027497276636
04027497276639040274972766394027497276639

GMDN Terms#

Term, Definition table
TermDefinition
Podiatric bur, single-useA rotary abrasive device typically used by a podiatrist intended to debride excrescences and treat conditions such as heavy toenails and/or plantar calluses. It consists of a well-differentiated head of various shapes (e.g., cone, cylinder, inverted cone, pear) made of hard materials (e.g., diamond, metal carbide), and a tapered, notched or elongated proximal end intended to fit into an appropriate powered handpiece (not included); it may be composed of two separate pieces. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329277813
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04027497285884"GT PODO 0.276 in (7 mm) round Shank 3/32"""A6510007220061A65100072200612026-02-11
14027497268945SK PODO 0.197 in (5 mm) round orange - coarseA611000520800061A6110005208000612026-02-10
14027497268952SK PODO 0.197 in (5 mm) round orange - fineA611000523200061A6110005232000612026-02-10
14027497276544SK PODO 0.276 in (7 mm) round orange - coarseA611000720800061A6110007208000612026-02-10
14027497276551SK PODO 0.276 in (7 mm) pointed orange - coarseA611000730800061A6110007308000612026-02-10
14027497276605SK PODO 0.276 in (7 mm) pointed orange - mediumA611000731500061A6110007315000612026-02-10
14027497276612SK PODO 0.394 in (10 mm) round orange - coarseA611001020800061A6110010208000612026-02-10
14027497276636SK PODO 0.394 in (10 mm) round orange - mediumA611001021500061A6110010215000612026-02-10
14027497276667SK PODO 0.394 in (10 mm) round orange - fineA611001023200061A6110010232000612026-02-10
14027497276681SK PODO 0.394 in (10 mm) pointed orange - coarseA611001030800061A6110010308000612026-02-10
14027497276704SK PODO 0.394 in (10 mm) pointed orange - mediumA611001031500061A6110010315000612026-02-10
14027497276728SK PODO 0.512 in (13 mm) round orange - coarseA611001320800061A6110013208000612026-02-10
04027497285822"GT PODO 0.394 in (10 mm) round Shank 3/32"""A6510010220061A65100102200612026-02-10
04027497285907"GT PODO 0.276 in (7 mm) pointed Shank 3/32"""A6510007320061A65100073200612026-02-10
04027497285914"GT PODO 0.394 in (10 mm) pointed Shank 3/32"""A6510010320061A65100103200612026-02-10
04027497285952"GT PODO 0.512 in (13 mm) round Shank 3/32"""A6510013220061A65100132200612026-02-10
04027497268948SK PODO 0.197 in (5 mm) round orange - coarseA611000520800061A6110005208000612026-02-10
04027497268955SK PODO 0.197 in (5 mm) round orange - fineA611000523200061A6110005232000612026-02-10
04027497276547SK PODO 0.276 in (7 mm) round orange - coarseA611000720800061A6110007208000612026-02-10
04027497276554SK PODO 0.276 in (7 mm) pointed orange - coarseA611000730800061A6110007308000612026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613053232KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613054222KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613167298KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613205525KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613266892KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268599KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268612KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268650KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226021289G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226021291G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226031156AU1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226017146A11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226046554A11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001998KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613002322KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613266915KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613267578KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613272435KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613273418KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31