FDA.reportPublic FDA data

Gill

Primary DI
00850047707260
Brand
Gill
Company
The Radebaugh-Fetzer Company
Model
883163
Catalog number
883163
Device description
G-91 Spatula and Packer 5 1/2"
Published
2023-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXRSpatula, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXRSpatula, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047707260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047707260008500477072608500477072600850047707260

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-878-4700customerservice@gillpodiatry.com

Regulatory Flags#

DUNS number
017823170
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047707000Gill8801438801432023-06-01
00850047707017Gill8803438803432023-06-01
00850047707024Gill8804838804832023-06-01
00850047707031Gill8807238807232023-06-01
00850047707048Gill8807638807632023-06-01
00850047707055Gill8807438807432023-06-01
00850047707062Gill8807838807832023-06-01
00850047707079Gill8808438808432023-06-01
00850047707086Gill8808638808632023-06-01
00850047707093Gill8811438811432023-06-01
00850047707109Gill8811638811632023-06-01
00850047707116Gill8813038813032023-06-01
00850047707123Gill8813438813432023-06-01
00850047707130Gill8813838813832023-06-01
00850047707147Gill8814038814032023-06-01
00850047707154Gill8815038815032023-06-01
00850047707161Gill8815438815432023-06-01
00850047707178Gill8815838815832023-06-01
00850047707185Gill8818038818032023-06-01
00850047707192Gill8818638818632023-06-01

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Primary DI, Brand, Company table
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M36841601GrafcoGF HEALTH PRODUCTS, INC.HXR2021-06-03
00840314220134gSourceGSOURCE LLCHXR2020-11-02
00840314220202gSourceGSOURCE LLCHXR2020-11-02