FDA.reportPublic FDA data

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

Primary DI
04027497276660
Brand
SK PODO 0.394 in (10 mm) round orange - fine
Company
LUKAS-ERZETT GmbH & Co. KG
Model
A611001023200061
Catalog number
A611001023200061
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
14027497276667PrimaryGS10
04027497276660Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1402749727666714027497276667
04027497276660040274972766604027497276660

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

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Primary DI, Brand, Company table
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