FDA.reportPublic FDA data

Another Hand

Primary DI
06009900639604
Brand
Another Hand
Company
WISMED PL SP Z O O
Model
1
Device description
The multi-joint, flexible medical holding/positioning device, approximately 20 cm long and made of thermoplastics, features a spring-loaded clamp mechanism on both ends conveniently able to attach to various diameter instruments/devices.
Published
2025-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYJHolder, Ureteral Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009900639604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009900639604060099006396046009900639604

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle gripA device designed specifically to be attached to the handle (or holding portion) of a surgical instrument to provide grip for improved manipulation of the handle during surgical procedures. It is typically a synthetic polymer device designed for attachment to a handle and is not intended to provide a physical sterile barrier between the handle and the hand of a healthcare professional (i.e., not a handle cover). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (513) 604-3430info@acemedicalco.com
+1 800.822.0314info@acemedicalco.com

Regulatory Flags#

DUNS number
850665825
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05906168942228Dual Action Pump Hand12025-03-17
06009900408316Peditrol12025-03-17
05906168942211Dual Action Pump Foot12025-03-17
05906168942235Sealing Connector Y piece12025-03-17
05906168942242Sealing Connector I Piece 12025-03-17
05906168942259Sealing Connector T piece12025-03-17
16009900408313Peditrol12025-03-17
06009900408330Smart Bulb12025-03-17
06009900408439Mini Pillow12025-03-17
59061689422282Dual Action Pump Hand12025-03-17

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Primary DI, Brand, Company table
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20653160386367CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEYJ2025-02-14
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00000000000000Leica BiosystemsLeica Biosystems Richmond, Inc.EYJ2024-12-16