FDA.reportPublic FDA data

DOOLEN BONE HOLDING CLAMP

Primary DI
00192896053649
Brand
DOOLEN BONE HOLDING CLAMP
Company
SONTEC INSTRUMENTS, INC.
Model
1103-846R
Catalog number
1103-846R
Device description
DOOLEN BONE HOLDING CLAMP WITH SPEED LOCK ANGLED TIP
Published
2018-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXDCLAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896053649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896053649001928960536491928960536490192896053649

GMDN Terms#

Term, Definition table
TermDefinition
Bone clamp traction barA manual surgical device designed to bridge two opposing bone clamps being used as a pair, one on either side of a fracture (the proximal and distal segment of a fractured bone) that is being approximated during orthopaedic surgery. It is attached to the stem of each of the bone clamps and using its screw mechanism, the fracture is drawn together by the surgeon. It is typically made of high-grade stainless steel and is designed for this function only. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length5.5Inch

Sterilization Methods#

Method table
Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
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
00192896015104REEH STITCH SCISSORS13-832513-83252018-09-12
00192896062238RYDER NEEDLE HOLDER2300-3152300-3152018-09-12
00192896105171Small Plates355-236A355-236A2020-10-05
00192896122833Intraocular Set1100-034-SET1100-034-SET2026-03-19
00192896122840Alyea-Babcock Vasectomy Clamp516-695516-6952026-03-19
00192896122857Diamond Head Grasping Forceps1273-1251273-1252026-03-19
00192896122864Velociraptor Junior Rongeur1273-171F1273-171F2026-03-19
00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
00192896122949Deluxe Alligator Grasping Forceps1100-333D1100-333D2026-03-19
00192896122680Schroeder Vulsellum Bone Clamp1103-0641103-0642026-03-10
00192896122697Cooley Vascular Clamp2100-527C2100-527C2026-03-10
00192896122703Ochsner Dissector2700-155T2700-155T2026-03-10
00192896122710Debakey Coarctation Clamp2100-6312100-6312026-03-10
00192896122727Debakey Coarctation Clamp2100-6352100-6352026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896122680Schroeder Vulsellum Bone ClampSONTEC INSTRUMENTS, INC.HXD2026-03-10
B356JD259280American MedicalsAmerican MedicalsHXD2026-03-09
00190776416706MillenniumAvalign Technologies, Inc.HXD2026-02-20
00190776415877MillenniumAvalign Technologies, Inc.HXD2026-02-04
00810123209781Adler Instrument CompanyAdler, Inc.HXD2026-01-28
00810123209798Adler Instrument CompanyAdler, Inc.HXD2026-01-28
00841013124532American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124549American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124556American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124563American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00888480670728Timberline Lateral Fusion SystemHighridge Medical, LLCHXD2025-12-18
05060624126697CS Fixed Blade ClampCARE SURGICAL LIMITEDHXD2025-12-17
03662663196741Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
03662663196758Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
03662663196796Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
09421038410479Enztec Inverted Premium Patella ClampENZTEC LIMITEDHXD2025-12-11
09421038410486Enztec Premium Cement Clamp - RotatingENZTEC LIMITEDHXD2025-12-11
00840277133113Innomed, Inc.INNOMED, INC.HXD2025-12-02
00840338603685Tornier HRS MaxTORNIER, INC.HXD2025-11-18
00840338603944Tornier HRS MaxTORNIER, INC.HXD2025-11-18
03662663137027Polaris 4.75 Deformity SystemHighridge Medical, LLCHXD2025-11-14
00840277133038Innomed, Inc.INNOMED, INC.HXD2025-11-12
00885556768471EVOSSmith & Nephew, Inc.HXD2025-11-12
00885556908846EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911112EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911129EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911136EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911143EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911150EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911167EVOSSmith & Nephew, Inc.HXD2025-11-11