FDA.reportPublic FDA data

BOSS Instruments

Primary DI
00888515048324
Brand
BOSS Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
45-7010
Catalog number
45-7010
Device description
McDougal Prostatectomy Clamp, right
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFNCLAMP, NON-ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFNClamp, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888515048324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515048324008885150483248885150483240888515048324

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888515202146BOSS Instruments77-322077-32202024-02-28
00888515328037BOSS InstrumentsVSX233VSX2332025-10-28
00888515328044BOSS InstrumentsVSG511VSG5112025-10-28
00888515272026Stealth SurgicalSS3923SS39232016-10-01
00888515272040Stealth SurgicalSS3925SS39252016-10-01
00888515272064Stealth SurgicalSS3927SS39272016-10-01
00888515217515BOSS Instruments80-624080-62402024-02-28
00888515217522BOSS Instruments80-624280-62422024-02-28
00888515217539BOSS Instruments80-624480-62442024-02-28
00888515217546BOSS Instruments80-624680-62462024-02-28
00888515217553BOSS Instruments80-624880-62482024-02-28
00888515217560BOSS Instruments80-625080-62502024-02-28
00888515217577BOSS Instruments80-625280-62522024-02-28
00888515217584BOSS Instruments80-625380-62532024-02-28
00888515217591BOSS Instruments80-625480-62542024-02-28
00888515217638BOSS Instruments80-626080-62602024-02-28
00888515217645BOSS Instruments80-626180-62612024-02-28
00888515217683BOSS Instruments80-627080-62702024-02-28
00888515217690BOSS Instruments80-627580-62752024-02-28
00888515217706BOSS Instruments80-627880-62782024-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776418472MillenniumAvalign Technologies, Inc.FFN2026-03-25
00190776415747MillenniumAvalign Technologies, Inc.FFN2026-02-04
00840183530341BR Surgical, LLCBR Surgical, LLCFFN2025-09-05
04049047072898GimmiGimmi GmbHFFN2025-04-02
00840183526979BR Surgical, LLCBR Surgical, LLCFFN2024-05-30
00888515048317BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00888515048362BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00888515326705BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00190776305512MillenniumAvalign Technologies, Inc.FFN2023-11-16
00190776248321AvalignAvalign Technologies, Inc.FFN2023-09-28
00190776248826AvalignAvalign Technologies, Inc.FFN2023-09-28
00190776293840MILLENNIUMAvalign Technologies, Inc.FFN2023-09-28
00190776329297MILLENNIUMAvalign Technologies, Inc.FFN2023-09-28
00190776329303MILLENNIUMAvalign Technologies, Inc.FFN2023-09-28
00841645112396ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645112419ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645141952ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645142447ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645142706ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645103332ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109877ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109884ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109891ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109907ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109914ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109921ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109938ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109945ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109952ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109969ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27