FDA.reportPublic FDA data

Disposable Monopolar Atraumatic Intestinal Forceps

Primary DI
16955797731082
Brand
Disposable Monopolar Atraumatic Intestinal Forceps
Company
Unimicro Medical Systems (ShenZhen) Co., Ltd.
Model
MAI905330
Published
2025-08-27
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142208000Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd.2015-04-13GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16955797731082PackageGS110In Commercial Distribution
36955797731086PackageGS14In Commercial Distribution
06955797731085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695579773108216955797731082
3695579773108636955797731086
06955797731085069557977310856955797731085

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421327368
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06955797714033Visible TrocarVTRDSB12102025-09-28
16955797714030Visible TrocarVTRDSB12102025-09-28
06955797710707Bladeless TrocarBTRDFA12102025-09-03
06955797714019Visible TrocarVTRDSB05102025-09-03
06955797715047Hasson TrocarHTRRSB12102025-09-03
06955797760023Auto-locking TrocarUNTR-A05102025-09-03
06955797760047Auto-locking TrocarUNTR-A10102025-09-03
06955797760061Auto-locking TrocarUNTR-A11102025-09-03
06955797760085Auto-locking TrocarUNTR-A12102025-09-03
06955797761020Bladeless TrocarUNTR-B05102025-09-03
06955797761037Bladeless TrocarUNTR-B05152025-09-03
06955797761044Bladeless TrocarUNTR-B10102025-09-03
06955797761068Bladeless TrocarUNTR-B11102025-09-03
06955797761082Bladeless TrocarUNTR-B12102025-09-03
06955797761099Bladeless TrocarUNTR-B12152025-09-03
06955797761105Bladeless TrocarUNTR-B15102025-09-03
06955797761112Bladeless TrocarUNTR-B15152025-09-03
06955797762010Visible TrocarUNTR-C05072025-09-03
06955797762027Visible TrocarUNTR-C05102025-09-03
06955797762034Visible TrocarUNTR-C05152025-09-03

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Primary DI, Brand, Company table
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08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
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08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14