FDA.report

ACE

Primary DI
00614950021895
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
0531013
Catalog number
0531013
Device description
JAR DRESSING 1/2QT STAINLESS STEEL 4-1/8"X3-1/4"
Published
2019-10-19
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614950021895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614950021895006149500218956149500218950614950021895

GMDN Terms

TermDefinition
Applicator jarA cylindrical vessel designed for holding various types of applicators (e.g., swabs, towelettes) in a clean container to reduce the possibility of contamination and to be ready for use. It is typically made of high-grade stainless steel, glass, or less frequently sterilizable plastic material (e.g., polypropylene). It will have a wide or weighted base to give it stability and a tightly sealed cover (lid). It is frequently used in ear/nose/throat (ENT) procedures, as well as procedures on the eyes, or the vagina and used in, e.g., an examination room, a doctor's surgery, or the sterile field during a surgical intervention. This is a reusable device.

Device Sizes

TypeValueUnit
Height3.25Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)441-3100ritaknight@acesurgical.com

Regulatory Flags

DUNS number
042763706
Device count
1
DM exempt
true
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

Other Devices From This Company

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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

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