FDA.reportPublic FDA data

Compression Staple System

Primary DI
00846832055456
Brand
Compression Staple System
Company
TORNIER, INC.
Model
STP-054S
Catalog number
STP-054S
Device description
TAMP
Published
2022-08-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXGTAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832055456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832055456008468320554568468320554560846832055456

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846832077632PERFORM™ HUMERAL SYSTEMDWR13602020-11-10
00846832077649PERFORM™ HUMERAL SYSTEMDWR13632020-11-10
00846832077656PERFORM™ HUMERAL SYSTEMDWR13662020-11-10
00846832077663PERFORM™ HUMERAL SYSTEMDWR13902020-11-10
00846832077670PERFORM™ HUMERAL SYSTEMDWR13932020-11-10
00846832077687PERFORM™ HUMERAL SYSTEMDWR13962020-11-10
00846832077694PERFORM™ HUMERAL SYSTEMDWR23602020-11-10
00846832077700PERFORM™ HUMERAL SYSTEMDWR23632020-11-10
00846832077717PERFORM™ HUMERAL SYSTEMDWR23662020-11-10
00846832077724PERFORM™ HUMERAL SYSTEMDWR23902020-11-10
00846832077731PERFORM™ HUMERAL SYSTEMDWR23932020-11-10
00846832077748PERFORM™ HUMERAL SYSTEMDWR23962020-11-10
00846832077755PERFORM™ HUMERAL SYSTEMDWR24202020-11-10
00846832077762PERFORM™ HUMERAL SYSTEMDWR24232020-11-10
00846832077779PERFORM™ HUMERAL SYSTEMDWR24262020-11-10
00846832077786PERFORM™ HUMERAL SYSTEMDWR33302020-11-10
00846832077793PERFORM™ HUMERAL SYSTEMDWR33332020-11-10
00846832077809PERFORM™ HUMERAL SYSTEMDWR33362020-11-10
00846832077816PERFORM™ HUMERAL SYSTEMDWR33602020-11-10
00846832077823PERFORM™ HUMERAL SYSTEMDWR33632020-11-10

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Primary DI, Brand, Company table
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00190376700717IdentiTiALPHATEC SPINE, INC.HXG2026-02-10
00810112598902TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXG2026-02-10
00190776415723MillenniumAvalign Technologies, Inc.HXG2026-02-04
04026575341153Endo-Model Knee Fusion Nail SK InstrumentsWALDEMAR LINK GmbH & Co. KGHXG2026-02-02
00840180543429General InstrumentsALPHATEC SPINE, INC.HXG2025-12-31
00840180543597General InstrumentsALPHATEC SPINE, INC.HXG2025-12-31
00840180543757General InstrumentsALPHATEC SPINE, INC.HXG2025-12-31
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03662663246620Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
03662663254113Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
03662663254120Alta ACDF SystemHighridge Medical, LLCHXG2025-12-16
00190376662176IdentiTi IIALPHATEC SPINE, INC.HXG2025-12-08
00199150041930Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXG2025-11-20
03662663070942TMT InstrumentsHighridge Medical, LLCHXG2025-11-16
03662663071581TMT InstrumentsHighridge Medical, LLCHXG2025-11-16
00888480363101C-THRU Anterior Spinal Spacer SystemHighridge Medical, LLCHXG2025-11-14
00888480637370Breckenridge ACDF SystemHighridge Medical, LLCHXG2025-11-14