FDA.report

Stablecut®

Primary DI
00846795020591
Brand
Stablecut®
Company
SYNVASIVE TECHNOLOGY, INC.
Model
11-4137
Published
2017-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846795020591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846795020591008467950205918467950205910846795020591

GMDN Terms

TermDefinition
Oscillating surgical saw blade, single-useA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90? angle to its shaft. It cuts when it is moved in a rapid oscillating motion. This device enables side-cutting action to be performed within a restricted-access area. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length90Millimeter
Width13Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags

DUNS number
968318621
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00889024367289N/A00-0032-015-0000-0032-015-002020-09-23
00889024430273NEO CLASSIC™20-8012-010-4720-8012-010-472016-07-07
00846795023677Stablecut®2299100022017-02-17
00846795023684Stablecut®2299100012017-02-17
00846795026357Stablecut®5060972017-02-17
00846795026364Stablecut®5060982017-02-17
00846795026524Stablecut®5061132017-02-17
00846795026548Stablecut®5061092017-02-17
00846795026555Stablecut®5061142017-02-17
00846795026579Stablecut®5061112017-02-17
00846795026586Stablecut®5061122017-02-17
00846795026609Stablecut®5061102017-02-17
00846795026678Stablecut®5061262017-02-17
00846795026692Stablecut®5061272017-02-17
00846795026852Stablecut®5061402017-02-17
00846795026869Stablecut®5061412017-02-17
00846795026876Stablecut®5061422017-02-17
00889024355590eLIBRA® 20-8012-000-012016-07-07
00889024355606eLIBRA® 20-8012-000-0220-8012-000-022016-07-07
00889024355637LIBRA20-8012-010-0120-8012-010-012016-07-07

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