FDA.reportPublic FDA data

SK THERMO 0.512 in (13 mm) round purple - coarse

Primary DI
04027497268788
Brand
SK THERMO 0.512 in (13 mm) round purple - coarse
Company
LUKAS-ERZETT GmbH & Co. KG
Model
A610801320800061
Catalog number
A610801320800061
Published
2026-01-20
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
14027497268785PrimaryGS10
04027497268788Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1402749726878514027497268785
04027497268788040274972687884027497268788

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
24053613296209Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-20
07613327687637N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687644N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687651N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687668N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687675N/ASTRYKER CORPORATIONGFF2026-03-19
24053613295929Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613295936Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296131Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296193Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296803Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297121Bur, cylindrical, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297190Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297206Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297220Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
10888867516950Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517926Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517933Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517940Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517957Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517964Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544052Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544069Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544076Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544083Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544090Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544106Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544120Arthrex®ARTHREX, INC.GFF2026-03-03
04027497285884"GT PODO 0.276 in (7 mm) round Shank 3/32"""LUKAS-ERZETT GmbH & Co. KGGFF2026-02-11
04027497285822"GT PODO 0.394 in (10 mm) round Shank 3/32"""LUKAS-ERZETT GmbH & Co. KGGFF2026-02-10