FDA.report

Symmetry Surgical®

Primary DI
00887482000274
Brand
Symmetry Surgical®
Company
SYMMETRY SURGICAL INC.
Model
14-1021
Catalog number
14-1021
Device description
Symmetry® Guide, Bailey Gigli Saw, Curved, 12 in
Published
2022-08-25
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

Related Records

Contact Domains

Product Codes

CodeName
GDRSaw, Manual And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GDRSaw, Manual And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887482000274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482000274008874820002748874820002740887482000274

GMDN Terms

TermDefinition
Manual surgical saw blade, flexible, reusableA flexible, wire-like, metal surgical instrument, usually of a high-grade stainless steel, typically intended to be used in orthopaedic or neurological surgery to cut bone. It has a serrated surface, or a surface coated with an abrasive material, and functions as the cutting blade of a flexible manual hand saw commonly known as a Gigli saw. This is a reusable device.

Device Sizes

TypeValueUnit
Length12Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags

DUNS number
079641356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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