FDA.reportPublic FDA data

Synergetics

Primary DI
20841305108435
Brand
Synergetics
Company
SYNERGETICS USA, INC.
Model
65963
Catalog number
65963
Device description
23ga VersaVIT™ Vitrectomy Probe, 6ft
Published
2016-09-20
Public version status
Update
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
HQEInstrument, vitreous aspiration and cutting, ac-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841305108435PrimaryGS10
10841305101958Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084130510843520841305108435
1084130510195810841305101958

GMDN Terms#

Term, Definition table
TermDefinition
Vitrectomy system micro-cutting unitA sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021056726
Device count
6
DM exempt
true
Premarket exempt
false
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
20841305107599Synergetics18067180672020-09-18
20841305107636Synergetics31.0231.022020-09-18
20841305107643Synergetics41.0041.002020-09-18
20841305107711Synergetics16579165792020-09-18
20841305107735Synergetics12.06.2512.06.252020-09-18
20841305107780Synergetics17570175702017-12-30
20841305107797Synergetics17580175802020-09-18
20841305107803Synergetics17680176802020-09-18
20841305107810Synergetics19020190202020-09-18
20841305107896Synergetics30.08.2330.08.232020-09-18
20841305107902Synergetics30.08.2530.08.252020-09-18
20841305107919Synergetics30.08.2730.08.272020-09-18
20841305107926Synergetics30.1030.102020-09-18
20841305107933Synergetics30.10.2330.10.232020-09-18
20841305107940Synergetics30.11.2330.11.232020-09-18
20841305107957Synergetics30.32.2330.32.232020-09-18
20841305107964Synergetics30.32.2530.32.252020-09-18
20841305107971Synergetics30.80.2530.80.252020-09-18
20841305107988Synergetics30.9030.902020-09-18
20841305107995Synergetics40.01-640.01-62020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251954900014Phaco Handpiece Sophi ECOThis AGHQE2026-02-11
10380650003291UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003307UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003314UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003611UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003628UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003635UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003666UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003673UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003680UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003772UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003789UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003796UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003802UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003840UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003857UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650004298UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004776UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004806UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004868UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004875UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005162UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005179UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005186UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005193UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650007923UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650007947UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008050UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008067UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008074UNITYAlcon Laboratories, Inc.HQE2025-04-08