FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770668519
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
SP7-70368
Catalog number
SP7-70368
Device description
ARNOLD SCLERAL DEPRESSOR
Published
2025-08-05
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
HNIRetractor, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770668519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770668519007577706685197577706685190757770668519

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular retractor, reusableA dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. 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
00190776418007MillenniumAvalign Technologies, Inc.HNI2026-03-23
00757770668427Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770708260Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770652518Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
00757770668083Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
G2231109830Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2025-08-11
00757770421985Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770423934Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770455720Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770510405Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770437429Bausch + LombBausch & Lomb IncorporatedHNI2025-08-05
00194613005924MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613005948MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613085896MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613104177MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
04058935011826Berke-Jaeger Lid PlateBausch & Lomb GmbHHNI2025-07-11
00850003089362N/AOptalmed, LLCHNI2025-07-07
G346EC1150Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNI2025-06-26
00190776401276MillenniumAvalign Technologies, Inc.HNI2025-06-10
G412H17300MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412H17350MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62010MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62020MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62680MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62690MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62700MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH65760MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH65790MR PHACOCrestpoint Management LimitedHNI2025-06-07
00817489026267Disposable Iris Retractor HooksKATALYST SURGICAL LLCHNI2025-04-28
00757770410613Bausch + LombBausch & Lomb IncorporatedHNI2025-04-17