FDA.reportPublic FDA data

GRAFCO

Primary DI
M36831711
Brand
GRAFCO
Company
GF HEALTH PRODUCTS, INC.
Model
3171
Device description
DOUBLE SIDED RAZOR BLADE
Published
2024-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GFABlade, Saw, General & Plastic Surgery, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M36831712PackageHIBCC100In Commercial Distribution
M36831711PrimaryHIBCC0
M36831710Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Razor bladeA device with an extremely sharp cutting edge intended to be inserted into a reusable razor to enable hair removal. It comes in various designs, traditionally with two cutting edges (one on either side of the blade's width). Though this device is reusable and designed to be used until blunted, it is for single-patient use to reduce the risk of cross-infection. Some types can be purposely broken into smaller segments to be used like a scalpel to cut tissue, e.g., during certain ophthalmologic surgical procedures. This is a reusable device.

Regulatory Flags#

DUNS number
132016168
Device count
250
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368FR601EPCHBN04271LUMEXFR601EPCHBN-04272026-09-18
M368FR601EPCHBN96071LUMEXFR601EPCHBN-96072026-09-18
M368FR601EPCHNN04271LUMEXFR601EPCHNN-04272026-09-18
M368FR601EPCNBN04271LUMEXFR601EPCNBN-04272026-09-18
M368FR601EPCNNN04271LUMEXFR601EPCNNN-04272026-09-18
M368FR601EPCOBN04271LUMEXFR601EPCOBN-04272026-09-18
M368FR601EPCONN04271LUMEXFR601EPCONN-04272026-09-18
M368FR601EPNHBN04271LUMEXFR601EPNHBN-04272026-09-18
M368FR601EPNHNN04271LUMEXFR601EPNHNN-04272026-09-18
M368FR601EPNHNN86021LUMEXFR601EPNHNN-86022026-09-18
M368FR601EPNNBN04271LUMEXFR601EPNNBN-04272026-09-18
M368FR601EPNNBN86041LUMEXFR601EPNNBN-86042026-09-18
M368FR601EPNNNN03171LUMEXFR601EPNNNN-03172026-09-18
M368FR601EPNNNN04271LUMEXFR601EPNNNN-04272026-09-18
M368FR601EPNOBN04271LUMEXFR601EPNOBN-04272026-09-18
M368FR601EPNONN04271LUMEXFR601EPNONN-04272026-09-18
M368FR601EPNONN13111LUMEXFR601EPNONN-13112026-09-18
M368FR601EUCHBN04271LUMEXFR601EUCHBN-04272026-09-18
M368FR601EUCHNN04271LUMEXFR601EUCHNN-04272026-09-18
M368IN601EPCHBNCOM1INTENSAIN601EPCHBN-COM2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14053613048177KOMET Surgical Saw BladeGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286142Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286159Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286166Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286180Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286210Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286234Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286258Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286265Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286272Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286296Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286319Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286333Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286340Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286517Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286715Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286821Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613286982Oscillating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD IIGebr. Brasseler GmbH & Co. KGGFA2026-09-18
14053613295717Reciprocating Saw Blade - for VELYS™ Power Large, BPL II, TRS, CAD II, UNIUMGebr. Brasseler GmbH & Co. KGGFA2026-09-18
00810111227421Saw BladeTreace Medical Concepts, Inc.GFA2026-08-25
00810111227445Saw BladeTreace Medical Concepts, Inc.GFA2026-08-25
37630055512506Long Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2026-08-25
37630055512537Long Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2026-08-25
37630055512568Long Bullnose Blade 32x0.6mmBien-Air Surgery SAGFA2026-08-25
47630055512503Long Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2026-08-25
47630055512534Long Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2026-08-25
47630055512565Long Bullnose Blade 32x0.6mmBien-Air Surgery SAGFA2026-08-25
27630055512509Long Bullnose Blade 22x0.6mmBien-Air Surgery SAGFA2026-08-25
27630055512530Long Bullnose Blade 27x0.6mmBien-Air Surgery SAGFA2026-08-25
27630055512561Long Bullnose Blade 32x0.6mmBien-Air Surgery SAGFA2026-08-25