FDA.report

Symmety Surgical

Primary DI
00887482000281
Brand
Symmety Surgical
Company
SYMMETRY SURGICAL INC.
Model
14-1025
Catalog number
14-1025
Device description
Symmetry® Guide, Poppen Gigli Saw, 11 in
Published
2017-12-12
Public version status
Update
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
00887482000281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482000281008874820002818874820002810887482000281

GMDN Terms

TermDefinition
Manual surgical saw blade, flexibleA flexible, wire-like, metal surgical instrument, usually of a high-grade stainless steel, typically used in orthopaedic or neurological surgery for cutting bone. It has a serrated surface and functions as the cutting blade of a flexible manual hand saw which is commonly known as a Gigli saw. This is a reusable device.

Device Sizes

TypeValueUnit
Length11Inch

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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