FDA.reportPublic FDA data

ACE

Primary DI
18904148101522
Brand
ACE
Company
ACE MEDICAL DEVICES PRIVATE LIMITED
Model
NEO-45-QF
Device description
Quick-Fire, 45° Needle Electrode, Compatible with Olympus® Brand Resectoscope, Universal, Bipolar in Saline
Published
2025-04-28
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
FASElectrode, Electrosurgical, Active, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18904148101522PackageGS15In Commercial Distribution
08904148101525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890414810152218904148101522
08904148101525089041481015258904148101525

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a 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 controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
863357571
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904148101860ACELPS-12T-QFM2025-04-28
08904148101877ACELPW-12T-QFM2025-04-28
08904148101891ACELPO-12T-QFM2025-04-28
08904148106339ACELPO-45-QFM2025-05-03
08904148106353ACEL-NEO-45-QF2025-05-03
18904148106336ACELPO-45-QFM2025-05-03
18904148106350ACEL-NEO-45-QF2025-05-03
08904148101402ACEHEMI-O-QF2025-04-28
08904148101525ACENEO-45-QF2025-04-28
08904148101570ACEHEMI-W-QF2025-04-28
08904148101587ACELPW-12-QFM2025-04-28
08904148101600ACEHEMI-S-QF2025-04-28
08904148101617ACENES-45-QF2025-04-28
08904148101624ACELPS-30-QFM2025-04-28
08904148101822ACEL-HEMI-O-QF2025-04-28
08904148101839ACEL-LPO-45-QFM2025-04-28
08904148101846ACELPS-45-QFM2025-04-28
08904148101853ACENEW-45-QF2025-04-28
08904148102157ACEL-SN-O-QF2025-04-28
08904148102164ACEHEMI-OO-QF2025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904148106339ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
08904148106353ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
08904148101402ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101525ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101570ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101587ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101600ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101617ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101624ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101822ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101839ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101846ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101853ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101860ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101877ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101891ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102157ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102164ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102379ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148103628ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105868ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105875ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105882ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106322ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106346ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
10801334000707Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FAS2017-05-03
08714729875604Signature Series PROSURG INCFAS2016-09-30
07613327055313NASTRYKER CORPORATIONFAS2016-09-23
07613327055399NASTRYKER CORPORATIONFAS2016-09-23
07613327055405NASTRYKER CORPORATIONFAS2016-09-23