FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
20757770454949
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
DP8315
Catalog number
DP8315
Device description
NEEDLE MICROFLOW PLUS 15DEGREE
Published
2016-09-24
Public version status
Update
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
HQCUnit, Phacofragmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20757770454949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075777045494920757770454949

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
196603781
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
07630055210449Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210456Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210463Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210869Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210876Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210883Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055242884HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07630055243294Dynamic Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07640179410236SOPHI AThis AGHQC2026-02-11
07640179410755Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410779Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410793Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
07640179410007SOPHIThis AGHQC2026-02-10
07640179410090SOPHIThis AGHQC2026-02-10
07630003909104Oertli®Oertli-Instrumente AGHQC2025-12-19
07630003910339Oertli®Oertli-Instrumente AGHQC2025-12-19
00380650002976UNITYAlcon Laboratories, Inc.HQC2025-11-18
07630003920178Oertli®Oertli-Instrumente AGHQC2025-09-19
00850005541080MICOR Auto I/ACarl Zeiss Meditec, Cataract Technology, Inc.HQC2025-08-19
00757770684571Bausch + LombBausch & Lomb IncorporatedHQC2025-07-18
10380650003208UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003215UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003222UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003239UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003352UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003369UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003376UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003383UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003437UNITYAlcon Laboratories, Inc.HQC2025-04-07
00380650003447UNITYAlcon Laboratories, Inc.HQC2025-04-07