FDA.reportPublic FDA data

Xpand

Primary DI
00813059013934
Brand
Xpand
Company
Diamatrix
Model
346722
Device description
Xpand X1 Ready-Loaded Iris Speculum, 6.7mm, Single-Use
Published
2019-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HOCClip, Iris Retractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOCClip, Iris RetractorOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813059013934PackageGS14In Commercial Distribution
00813059013927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059013934008130590139348130590139340813059013934
00813059013927008130590139278130590139270813059013927

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular retractor, single-useA sterile, 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 self-retaining ring/frame or a small hook-like device which may include a retention bead, and is usually designed to be manipulated using another ophthalmic instrument. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809555139
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810163790577Diamatrix Ltd.C6162026-05-26
00810163790553Diamatrix Ltd.G151G1512026-04-29
00813059013354Dacrios Opthalmic KnivesD3210D32102026-04-14
00810163790546Diamatrix Ltd.N04350.8N04350.82026-03-24
00813059013491Dacrios Opthalmic KnivesD3705D37052026-03-19
00810163790430Diamatrix Ltd.F003F0032025-10-21
00810163790447Diamatrix Ltd.H805-1.5H805-1.52025-10-21
00810163790454Diamatrix Ltd.H805-3H805-32025-10-21
00810163790461Diamatrix Ltd.F300S.5F300S.52025-10-21
00810163790478Inami & Co., Ltd.S-325S-3252025-10-20
00810163790423Diamatrix Ltd.C223A-25C223A-252025-10-07
00810163790416Diamatrix Ltd.F775S2025-08-06
00810163790386Diamatrix Ltd.C119-21C119-212025-06-30
00810163790393Diamatrix Ltd. H188FH188F2025-06-30
00810163790409Diamatrix Ltd.C027-8C027-82025-06-30
00810163790348Diamatrix Ltd.F002F0022025-06-13
00810163790317Diamatrix Ltd.H854H8542025-06-06
00810163790324Diamatrix Ltd.IT-.5-CIT-.5-C2025-06-06
00810163790331Diamatrix Ltd.F445S.5F445S.52025-05-27
00810163790355Diamatrix Ltd.F040-1.2F040-1.22025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613041533MSI Precision Specialty InstrumentsMed Saver, Inc.HOC2025-08-01
00194613103095MSI Precision Specialty InstrumentsMed Saver, Inc.HOC2025-08-01
08052276027054Set of 4 Iris RetractorsAKTIVE SRLHOC2024-01-11
08052276027061Set of 5 Iris RetractorsAKTIVE SRLHOC2024-01-11
08058340220970Set of 4 Iris RetractorsAKTIVE SRLHOC2024-01-11
08056477550502Set of 5 Iris RetractorsAKTIVE SRLHOC2024-01-11
04049368058045N.A.Geuder AktiengesellschaftHOC2023-07-06
04049368058199N.A.Geuder AktiengesellschaftHOC2023-07-06
00845819000458OASIS® Iris ExpanderOASIS MEDICAL, INC.HOC2023-06-30
00845819005200Disposable Instruments OASIS MEDICAL, INC.HOC2023-06-30
10845819000455OASIS® Iris ExpanderOASIS MEDICAL, INC.HOC2023-06-30
10845819005207Disposable Instruments OASIS MEDICAL, INC.HOC2023-06-30
00841668143452MAXIRIS FLEXIBLE IRIS RETRACTOR PACK/5KATENA PRODUCTS, INC.HOC2022-12-13
00841668143469MAXIRIS AKAHOSHI FLAT IRIS RETRACT PK/5KATENA PRODUCTS, INC.HOC2022-12-13
00841668143476MAXIRIS AKAHOSHI TW FIBR IRIS/CAP RETRACKATENA PRODUCTS, INC.HOC2022-12-13
00841668127377GRAETHER IRIS RETRACTOR STRAIGHTKATENA PRODUCTS, INC.HOC2022-12-07
00841668127384GRAETHER IRIS RETRACTOR ANGLEDKATENA PRODUCTS, INC.HOC2022-12-07
00841668118887Iris RetractorKATENA PRODUCTS, INC.HOC2022-11-16
00841668118894Iris RetractorKATENA PRODUCTS, INC.HOC2022-11-16
00841668119747Iris RetractorKATENA PRODUCTS, INC.HOC2022-11-16
00813059018403Diamatrix LtdDiamatrixHOC2022-10-31
00813059018397Diamatrix LtdDiamatrixHOC2022-10-31
00840319726105Hayden MedicalHayden Medical, Inc.HOC2022-08-16
30886158007037Visitec®Beaver-Visitec International, Inc.HOC2022-01-26
00886158007036Visitec®Beaver-Visitec International, Inc.HOC2022-01-26
00886158007043Visitec® I-Ring®Beaver-Visitec International, Inc.HOC2022-01-20
00850003089188N/AOptalmed, LLCHOC2021-03-10
00850003089201N/AOptalmed, LLCHOC2021-03-10
10850003089208N/AOptalmed, LLCHOC2021-03-10
00850003089034N/AOptalmed, LLCHOC2021-02-08