FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515034945
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
18-5069
Catalog number
18-5069
Device description
Kleinert Kutz Skin Hook, shrp, single, 7mm, 5"
Published
2024-02-27
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
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515034945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515034945008885150349458885150349450888515034945

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888515149311BOSS Instruments90-7060P90-7060P2024-12-11
00888515231184BOSS Instruments90-700590-70052024-12-11
00888515231191BOSS Instruments90-700790-70072024-12-11
00888515231207BOSS Instruments90-700990-70092024-12-11
00888515231214BOSS Instruments90-701190-70112024-12-11
00888515231221BOSS Instruments90-701390-70132024-12-11
00888515231238BOSS Instruments90-702090-70202024-12-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417901MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418335MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418366MillenniumAvalign Technologies, Inc.GDG2026-03-23
04052536215522tezoUlrich GmbH & Co. KGGDG2026-03-16
00810158219328PRINCETONPrinceton Medical Group, Inc.GDG2026-03-12
00190776417826MillenniumAvalign Technologies, Inc.GDG2026-03-11
00190776417673MillenniumAvalign Technologies, Inc.GDG2026-03-04
00190776417512MillenniumAvalign Technologies, Inc.GDG2026-02-27
00190776416775MillenniumAvalign Technologies, Inc.GDG2026-02-20
00190776415761MillenniumAvalign Technologies, Inc.GDG2026-02-04
00190776415204MillenniumAvalign Technologies, Inc.GDG2026-01-27
00198506087431ELMED INCORPORATEDELMED INCORPORATEDGDG2026-01-07
03662663277082Timberline Lateral Fusion SystemHighridge Medical, LLCGDG2025-12-18
03662663277099Timberline Lateral Fusion SystemHighridge Medical, LLCGDG2025-12-18
03662663192798Breckenridge ACDF SystemHighridge Medical, LLCGDG2025-12-15
03662663192804Breckenridge ACDF SystemHighridge Medical, LLCGDG2025-12-15
00190776415129MillenniumAvalign Technologies, Inc.GDG2025-12-03
03662663131230Disc Preparation InstrumentsHighridge Medical, LLCGDG2025-12-03
03662663131247Disc Preparation InstrumentsHighridge Medical, LLCGDG2025-12-03
09348811019653INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-12-02
09348811108647INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-28
09348811155368INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-28
00810207782605Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782612Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782629Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782636Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782643Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782650Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782667Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782674Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24