FDA.reportPublic FDA data

ACE

Primary DI
00614950019984
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
0800221
Catalog number
0800221
Device description
SCISSOR UNIVERSAL EMT 7" 18CM
Published
2019-10-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGNSCISSORS, SURGICAL TISSUE, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614950019984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950019984006149500199846149500199840614950019984

GMDN Terms#

Term, Definition table
TermDefinition
Bandage scissors, reusableA hand-held manual instrument intended to be used to cut bandages and cloth. Typically a robust instrument, it comprises two pivoted blades provided with finger and thumb holes in the handles. The distal end of the blades may be different shapes and are usually rounded for safety; one blade may extend in front of the other and have an olive tip that is placed under the bandage. It is typically made of high-grade stainless steel and some may use carbide inserts for the cutting edge. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No spcecial storage conditions required

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100ritaknight@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950031863BioPlugBH0054BH00542024-05-22
00614950031870BioStripBH00055BH000552024-05-22
00614950029525ACE400000140000012023-12-05
00614950029532ACE401500240150022023-12-05
00614950029549ACE400200740020072023-12-05
00614950029556ACE603901560390152023-12-05
00614950029563ACE603901660390162023-12-05
00614950029570ACE442305044230502023-12-05
00614950029587ACE090010209001022023-12-05
00614950029594Macan003333900333392023-12-05
00614950029600Macan526003552600352023-12-05
00614950029617Macan526003852600382023-12-05
00614950029624Macan526600052660002023-12-05
00614950029631Macan003334200333422023-12-05
00614950029648Macan526004552600452023-12-05
00614950029655Macan003333700333372023-12-05
00614950029662Macan526002652600262023-12-05
00614950029679ACE400520340052032023-12-05
00614950029686Macan003337600333762023-12-05
00614950029693Macan526002952600292023-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71090TBS BASICSACME ENTERPRISE.EGN2026-05-22
G149TBSB71100TBS BASICSACME ENTERPRISE.EGN2026-05-22
G149TBSB71110TBS BASICSACME ENTERPRISE.EGN2026-05-22
G149TBSB71120TBS BASICSACME ENTERPRISE.EGN2026-05-22
G149TBSB71130TBS BASICSACME ENTERPRISE.EGN2026-05-22
G149TBSB71140TBS BASICSACME ENTERPRISE.EGN2026-05-22
G149TBSB71170TBS BASICSACME ENTERPRISE.EGN2026-05-22
B382S3797050Surgical DirectSurgical Direct, Inc.EGN2026-03-09
B382S9038721000Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD9038721050Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD90390415L0Surgical DirectSurgical Direct, Inc.EGN2026-03-02
B382SD92011811070Surgical DirectSurgical Direct, Inc.EGN2026-03-02
G1493803706TBS DentalACME ENTERPRISE.EGN2026-03-02
G1493806507TBS DentalACME ENTERPRISE.EGN2026-03-02
B382S3488110Surgical DirectSurgical Direct, Inc.EGN2026-02-25
B382SD903220230Surgical DirectSurgical Direct, Inc.EGN2026-02-25
B382SD9032161010Surgical DirectSurgical Direct, Inc.EGN2026-02-20
B382SD9035171020Surgical DirectSurgical Direct, Inc.EGN2026-02-16
B382SD9036541000Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382SD90398411L0Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382SD90398511L0Surgical DirectSurgical Direct, Inc.EGN2026-02-05
B382S37921050Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382S37921060Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD59240Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6720800Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6720820Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD6780830Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD80840Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD9035401000Surgical DirectSurgical Direct, Inc.EGN2026-02-03
B382SD90378310040Surgical DirectSurgical Direct, Inc.EGN2026-02-03