FDA.report

Disposable Instruments

Primary DI
10845819005207
Brand
Disposable Instruments
Company
OASIS MEDICAL, INC.
Model
9700, 9700-S
Device description
OASIS® Iris Expander, 6.25mm
Published
2023-06-30
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

Related Records

Contact Domains

Product Codes

CodeName
HOCClip, Iris Retractor

Product Code Classifications

CodeDeviceSpecialtyClass
HOCClip, Iris RetractorOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10845819005207PackageGS15In Commercial Distribution
00845819005200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084581900520710845819005207
00845819005200008458190052008458190052000845819005200

GMDN Terms

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
Ethylene Oxide

Contacts

PhoneEmail
9093055400customerservice@oasismedical.com

Regulatory Flags

DUNS number
194121018
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10845819002985Surgeon's Choice CardSCK 2009, B-SCK 20092023-12-27
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10845819005481SOFT PLUG® Extended Duration Plugs5042023-07-31
00845819000076Oasis REST & RELIEF Eye MaskOM80002023-06-30
10845819000080SOFT PLUG® Silicone Punctum Plug6610-S, 6610, 6610-D2023-06-30
10845819000103SOFT PLUG® Silicone Punctum Plug6611-S, 6611, 6611-D2023-06-30
00845819000120SOFT PLUG® Silicone Punctum Plug6612-S, 6612, 6612-D2023-06-30
10845819000141SOFT PLUG® Silicone Punctum Plug6612-SFC, 6612-FC2023-06-30
10845819000172SOFT PLUG® Silicone Punctum Plug6613-S, 6613, 6613-D2023-06-30
10845819000202SOFT PLUG® Silicone Punctum Plug6614-S, 6614, 6614-D2023-06-30
10845819000226SOFT PLUG® Silicone Punctum Plug6614-SFC, 6614-FC2023-06-30
10845819000271FORM FIT® Hydrogel Canalicular Plug6303, 6303-T, B-63032023-06-30
10845819000318Lacrimal lntubation Set60042023-06-30

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04049368058045N.A.Geuder AktiengesellschaftHOC2023-07-06
04049368058199N.A.Geuder AktiengesellschaftHOC2023-07-06
10845819000455OASIS® Iris ExpanderOASIS MEDICAL, INC.HOC2023-06-30
00841668127377GRAETHER IRIS RETRACTOR STRAIGHTKATENA PRODUCTS, INC.HOC2022-12-07
00841668127384GRAETHER IRIS RETRACTOR ANGLEDKATENA PRODUCTS, INC.HOC2022-12-07
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00850003089225N/AOptalmed, LLCHOC2021-02-01
10850003089055N/AOptalmed, LLCHOC2021-02-01
18717872009640Iris Retractor.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HOC2021-01-07
18717872009657Iris Retractor.D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HOC2021-01-07
00810799031990Stephens InstrumentsKRISHNA IMPORTS INCHOC2020-09-22
00841668103685Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14
00841668103692Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14
00841668103708Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14
00841668103715Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14
00841668103722Iris RetractorKATENA PRODUCTS, INC.HOC2020-09-14