FDA.reportPublic FDA data

SK PODO 0.197 in (5 mm) round orange - coarse

Primary DI
14027497268945
Brand
SK PODO 0.197 in (5 mm) round orange - coarse
Company
LUKAS-ERZETT GmbH & Co. KG
Model
A611000520800061
Catalog number
A611000520800061
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
14027497268945PrimaryGS10
04027497268948Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1402749726894514027497268945
04027497268948040274972689484027497268948

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.

Regulatory Flags#

DUNS number
329277813
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
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
04027497276608SK PODO 0.276 in (7 mm) pointed orange - mediumA611000731500061A6110007315000612026-02-10

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Primary DI, Brand, Company table
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