Speed Hand and Wrist

GUDID 00810633021835

Drill Kit for Speed Hand and Wrist System

Biomedical Enterprises, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID00810633021835
NIH Device Record Key3b755ff5-a491-4d4c-aeb0-0122cfd46696
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeed Hand and Wrist
Version Model NumberDK-200HW
Company DUNS792619009
Company NameBiomedical Enterprises, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone210-881-0043
Emailgupton@bme-tx.com
Phone210-881-0043
Emailgupton@bme-tx.com
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone1-800-255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Dimensions

Outer Diameter2 Millimeter
Outer Diameter2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810633021835 [Primary]

FDA Product Code

KDDKit, Surgical Instrument, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-07
Device Publish Date2015-10-24

Devices Manufactured by Biomedical Enterprises, Inc.

00810633022047 - N/A2020-05-07 DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE
00810633022054 - N/A2020-05-07 DEPUY SYNTHES HAMMERTOE CCI LARGE KIT W/1.60 K-WIRE/ STERILE
00810633022085 - N/A2020-05-07 Speed 2.0mm Instrument Kit Comprehensive
00810633022092 - N/A2020-05-07 Speed 2.65mm Instrument Kit Comprehensive
00810633020005 - HammerLock2020-05-07 Medium, 19mm length Nitinol Intramedullary Implant
00810633020012 - HammerLock2020-05-07 Hammerlock implant for DIP
00810633020029 - HammerLock2020-05-07 Hammerlock X-Type Large
00810633020036 - HammerLock2020-05-07 Hammerlock Angled X-Type Large

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