FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770407224
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
M7500
Catalog number
M7500
Device description
NEEDLE HOLDER BAYONET JACOBSON
Published
2024-11-21
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

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories
FHQHolder, Needle, Gastroenterologic
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770407224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770407224007577704072247577704072240757770407224

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196603781
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
00757770406791Bausch + LombSP7-100227SP7-1002272026-02-11
00757770421848Bausch + LombSP7-100220SP7-1002202026-02-11
00757770428588Bausch + LombSP7-35740SP7-357402026-02-11
00757770676491Bausch + LombSP7-69525SP7-695252026-02-11
00757770682539Bausch + LombSP7-68756SP7-687562026-02-11
00757770712281Bausch + LombSP7-36090SP7-360902026-02-11
00757770714049Bausch + LombSP7-64085SP7-640852026-02-11
00757770714056Bausch + LombSP7-71927SP7-719272026-02-11
00757770425044Bausch + LombSP7-35203SP7-352032026-02-04
00757770429301Bausch + LombSP7-100217SP7-1002172026-02-04
00757770636631Bausch + LombSP7-62478SP7-624782026-02-04
00757770668427Bausch + LombSP7-66972SP7-669722026-02-04
00757770683741Bausch + LombSP7-70000SP7-700002026-02-04
00757770708260Bausch + LombSP7-55555SP7-555552026-02-04
00757770635382Bausch + LombE0130 1.8/2.2E0130 1.8/2.22026-01-27
00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
00310119041086Bausch & Lomb624423FCP-43602026-01-09
00310119041406Bausch + Lomb623909FCP-4278A2026-01-09
00310119041420Bausch + Lomb623994FCP-43732026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800195Adler Instrument CompanyAdler, Inc.FHQ2026-05-26
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00628101559618OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101595708OhioOHIO MEDICAL, LLCBYX2026-03-24
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00628101631567OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631574OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631628OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631635OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631642OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631673OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631680OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631703OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631710OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631727OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631734OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631741OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631758OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631802OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631819OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631826OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631833OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631871OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631888OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631918OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631925OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631932OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631949OhioOHIO MEDICAL, LLCBYX2026-03-23