FDA.report

Ambler Surgical

Primary DI
00190660164751
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Martin tornado plaster shears
Catalog number
78-783
Device description
Martin tornado plaster shears, 9 1/2'', angled blades, probe point tip, ring handle
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LGGINSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
LGGInstrument, Cast Application/Removal, ManualOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660164751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660164751001906601647511906601647510190660164751

GMDN Terms

TermDefinition
Cast cutting shearsA large, scissors-like, hand-held instrument whose blades distal to the pivot point terminate in various jaw configurations, capable of cutting heavy layers of plaster or synthetic material used to form hardened casts, i.e., that which has already been used to form a cast around a patient's limb or body part. The tip of one of the distal blades forming the scissors-like cutting mechanism is usually rounded along it bottom edge to prevent injury to the patient as the cast is cut. This device is typically made of high-grade stainless steel and will usually be provided with a spring mechanism to assist in opening the jaws. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags

DUNS number
015272206
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

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