FDA.reportPublic FDA data

PANGEA

Primary DI
07613327648362
Brand
PANGEA
Company
Stryker GmbH
Model
542161
Catalog number
542161
Device description
Torque Limiting Adapter 4.0Nm
Published
2026-06-02
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

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327648362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327648362076133276483627613327648362

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument torque limiterA small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886385017365STAR908-0110-02908-0110-022022-02-14
00886385018836STAR933-0003-02933-0003-022022-02-14
00886385018843STAR933-0003-03933-0003-032022-02-14
00886385019055STAR933-0025-02933-0025-022022-02-14
00886385019062STAR933-0025-03933-0025-032022-02-14
00886385019147STAR933-0029-02933-0029-022022-02-14
00886385017150STAR905-0066905-00662020-09-24
07613327350296NA2351-00202351-00202018-11-02
07613327361650NA2351-01402351-01402018-11-02
07613327361667NA2351-03402351-03402018-11-02
07613327361674NA2351-00302351-00302018-11-02
07613327361681NA2351-00602351-00602018-11-02
07613327361780NA2351-42902351-42902018-11-02
07613327368154NA2351-00702351-00702018-11-02
07613327368178NA2351-42802351-42802018-11-02
07613327376197NA2351-04202351-04202018-11-01
07613327376203NA2351-03802351-03802018-11-01
00886385016412STAR™400-2502017-06-27
00886385016429STAR™400-2512017-06-27
00886385016436STAR™400-2522017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-23
00850078396297TruPWR Torque Limiting Attachment Sterile, Single Use 90 in-lbEca Medical InstrumentsHWE2026-10-20
00850078396365PFT Adapter, DS, Mariner,105 in-lb (228-TXRX-009)Eca Medical InstrumentsHWE2026-10-20
00850078396372PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)Eca Medical InstrumentsHWE2026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
03700879515687Airlock®NOVASTEPHWE2026-08-25
08800038061286EZXIMEDICOM CO., LTD.HWE2026-08-25
00850083430108SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
10888857596719Xia® 3VB Spine LLCHWE2026-05-12
10888857596726Xia® 3VB Spine LLCHWE2026-05-12
10888857596733Xia® 3VB Spine LLCHWE2026-05-12
10888857578135Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578142Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578159Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578166Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578210Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578227Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578234Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578241Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20