FDA.reportPublic FDA data

Grafco

Primary DI
M36896780
Brand
Grafco
Company
GF HEALTH PRODUCTS, INC.
Model
9678
Catalog number
9678
Device description
SAFETY GLASSES, OUTDOOR
Published
2021-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M36896781PrimaryHIBCC0
M36896780Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye splash shield, reusableA device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
12
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
false
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
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209006799FielmannFielmann Group AGHQZ2026-07-14
04066209008311FielmannFielmann Group AGHQZ2026-07-14
04066209008885FielmannFielmann Group AGHQZ2026-07-14
04066209045118FielmannFielmann Group AGHQZ2026-07-14
04066209054578FielmannFielmann Group AGHQZ2026-07-14
04580822703694EYEVANEYEVAN INC.HQZ2026-07-10
04580822703724EYEVANEYEVAN INC.HQZ2026-07-10
04580822703731EYEVANEYEVAN INC.HQZ2026-07-10
04580822703748EYEVANEYEVAN INC.HQZ2026-07-10
04580822704264EYEVANEYEVAN INC.HQZ2026-07-10
04580822704271EYEVANEYEVAN INC.HQZ2026-07-10
04580822704288EYEVANEYEVAN INC.HQZ2026-07-10
04580822704295EYEVANEYEVAN INC.HQZ2026-07-10
04580822704561EYEVANEYEVAN INC.HQZ2026-07-10
04580822704578EYEVANEYEVAN INC.HQZ2026-07-10
04580822704585EYEVANEYEVAN INC.HQZ2026-07-10
04580822704592EYEVANEYEVAN INC.HQZ2026-07-10
04580822704837EYEVANEYEVAN INC.HQZ2026-07-10
04580822704844EYEVANEYEVAN INC.HQZ2026-07-10
04580822704851EYEVANEYEVAN INC.HQZ2026-07-10
04580822704868EYEVANEYEVAN INC.HQZ2026-07-10
04580822704998EYEVANEYEVAN INC.HQZ2026-07-10
04580822705018EYEVANEYEVAN INC.HQZ2026-07-10
04580822705025EYEVANEYEVAN INC.HQZ2026-07-10
04580822705049EYEVANEYEVAN INC.HQZ2026-07-10
04582669065393EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065409EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065416EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065454EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065461EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10