FDA.report

Ratcheting T-handle

Primary DI
00810097800496
Brand
Ratcheting T-handle
Company
SMV SCIENTIFIC LLC
Model
1252-5265
Catalog number
1252-5265
Device description
Ratcheting T-handle
Published
2022-02-17
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
true

Related Records

Contact Domains

Product Codes

CodeName
HXXScrewdriver
MDMInstrument, Manual, Surgical, General Use
OURSacroiliac Joint Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810097800496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097800496008100978004968100978004960810097800496

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags

DUNS number
089645059
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 DIBrandModelCatalogPublished
008100743000014.0 x 12mm Screw Super Fastener, ST340-2012340-20122023-06-12
008100743000184.0 x 14mm Screw Super Fastener, ST340-2014340-20142023-06-12
008100743000254.0 x 16mm Screw Super Fastener, ST340-2016340-20162023-06-12
008100743000324.0 x 18mm Screw Super Fastener, ST340-2018340-20182023-06-12
008100743000494.0 x 20mm Screw Super Fastener, ST340-2020340-20202023-06-12
008100743000564.0 x 22mm Screw Super Fastener, ST340-2022340-20222023-06-12
008100743000634.0 x 24mm Screw Super Fastener, ST340-2024340-20242023-06-12
008100743000704.0 x 26mm Screw Super Fastener, ST340-2026340-20262023-06-12
008100743000874.0 x 28mm Screw Super Fastener, ST340-2028340-20282023-06-12
008100743000944.0 x 30mm Screw Super Fastener, ST340-2030340-20302023-06-12
008100743001004.0 x 32mm Screw Super Fastener, ST340-2032340-20322023-06-12
008100743001174.0 x 34mm Screw Super Fastener, ST340-2034340-20342023-06-12
008100743001244.0 x 36mm Screw Super Fastener, ST340-2036340-20362023-06-12
008100743001314.0 x 38mm Screw Super Fastener, ST340-2038340-20382023-06-12
008100743001484.0 x 40mm Screw Super Fastener, ST340-2040340-20402023-06-12
008100743001554.0 x 42mm Screw Super Fastener, ST340-2042340-20422023-06-12
008100743001624.0 x 44mm Screw Super Fastener, ST340-2044340-20442023-06-12
008100743001794.0 x 46mm Screw Super Fastener, ST340-2046340-20462023-06-12
008100743001864.0 x 48mm Screw Super Fastener, ST340-2048340-20482023-06-12
008100743001934.0 x 50mm Screw Super Fastener, ST340-2050340-20502023-06-12

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