FDA.report

BOSS Instruments

Primary DI
00888515329478
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
79-1190
Catalog number
79-1190
Device description
Boss K-Wire, 9" Single Trocar, .035" Smooth, Non-Sterile 6pk
Published
2024-02-28
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

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888515329478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515329478008885153294788885153294780888515329478

GMDN Terms

TermDefinition
Orthopaedic trocar blade, reusableA rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags

DUNS number
848522678
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

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00888515231245BOSS Instruments90-702290-70222024-12-11
00888515231252BOSS Instruments90-702490-70242024-12-11
00888515231269BOSS Instruments90-702690-70262024-12-11
00888515231276BOSS Instruments90-702890-70282024-12-11
00888515231283BOSS Instruments90-703990-70392024-12-11
00888515231290BOSS Instruments90-7039P90-7039P2024-12-11
00888515231306BOSS Instruments90-704090-70402024-12-11
00888515231320BOSS Instruments90-7040P90-7040P2024-12-11
00888515231337BOSS Instruments90-704290-70422024-12-11
00888515231351BOSS Instruments90-7042P90-7042P2024-12-11
00888515231368BOSS Instruments90-704490-70442024-12-11
00888515231382BOSS Instruments90-7044P90-7044P2024-12-11
00888515231399BOSS Instruments90-704690-70462024-12-11

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