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

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
Premarket exempt
true
Lot or batch
true
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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