FDA.report

Grafco

Primary DI
M36841601
Brand
Grafco
Company
GF HEALTH PRODUCTS, INC.
Model
4160
Catalog number
4160
Device description
PLASTER SPREADER HENNIG
Published
2021-06-03
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

Related Records

Contact Domains

Product Codes

CodeName
HXRSpatula, Orthopedic

Product Code Classifications

CodeDeviceSpecialtyClass
HXRSpatula, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M36841601PrimaryHIBCC0

GMDN Terms

TermDefinition
Cast spreaderA hand-operated surgical instrument with specially designed blades used to separate and spread hardened plaster, i.e., that which has already been used to form a cast around a patient's limb or body part. It is designed like a large size forceps with flat serrated (serrated on the outer edge) blades that may be exchangeable and which are wedge-shaped (thin at the working end). These blades are prised between the cut plaster cast and pressure is exerted upon the handles by squeezing them together, forcing the plaster cast to separate. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags

DUNS number
132016168
Device count
1
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

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M368ESC2EYESTMBX1HAUSTEDESC2EYEST-MB-X2026-02-02
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M368ALX361AMERILUXALX362025-12-11
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00840314220134gSourceGSOURCE LLCHXR2020-11-02
00840314220202gSourceGSOURCE LLCHXR2020-11-02