FDA.report

gSource

Primary DI
00840314248473
Brand
gSource
Company
GSOURCE LLC
Model
gS 27.0660
Catalog number
gS 27.0660
Device description
WELLS ENUCLEATION SPOON WELLS ENUCLEATION SPOON
Published
2022-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNBSpoon, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNBSpoon, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840314248473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314248473008403142484738403142484730840314248473

GMDN Terms

TermDefinition
Lens spoonA hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye. It is typically made of high-grade stainless steel and has a spoon-shaped distal working end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
008162518
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 DIBrandModelCatalogPublished
00840314270221gSourcegS 82.7715gS 82.77152026-03-20
00840314270238gSourcegS 82.7717gS 82.77172026-03-20
00840314270245gSourcegS 86.8120gS 86.81202026-03-20
00840314270252gSourcegS 86.8125gS 86.81252026-03-20
00840314270269gSourcegS 86.8130gS 86.81302026-03-20
00840314238511gSourcegS 75.3124gS 75.31242025-11-24
00840314238528gSourcegS 75.3250gS 75.32502025-11-24
00840314238535gSourcegS 75.3280gS 75.32802025-11-24
00840314238542gSourcegS 75.9230gS 75.92302025-11-24
00840314238559gSourcegS 75.9240gS 75.92402025-11-24
00840314238566gSourcegS 75.9250gS 75.92502025-11-24
00840314238573gSourcegS 75.9255gS 75.92552025-11-24
00840314238580gSourcegS 75.9260gS 75.92602025-11-24
00840314238597gSourcegS 75.9282gS 75.92822025-11-24
00840314238603gSourcegS 75.9300gS 75.93002025-11-24
00840314238610gSourcegS 75.9302gS 75.93022025-11-24
00840314238627gSourcegS 75.9307gS 75.93072025-11-24
00840314238634gSourcegS 75.9308gS 75.93082025-11-24
00840314238641gSourcegS 75.9309gS 75.93092025-11-24
00840314238658gSourcegS 75.9310gS 75.93102025-11-24

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00194613004903MSI Precision Specialty InstrumentsMed Saver, Inc.HNB2024-08-15
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G2231137200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNB2023-08-30
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00841668129388GROOVED DONOR SPOONKATENA PRODUCTS, INC.HNB2022-12-07
00841668129876LEWIS LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668129920MORRISON LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668129975NEW ORLEANS LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668130018KANSAS LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668130025WILDER LENS LOOPKATENA PRODUCTS, INC.HNB2022-12-07
00841668130063BARRAQUER LENTICULAR SPOONKATENA PRODUCTS, INC.HNB2022-12-07
00841668130070CULLER LENS SPOONKATENA PRODUCTS, INC.HNB2022-12-07