FDA.report

EXMOOR

Primary DI
05060180251000
Brand
EXMOOR
Company
EXMOOR PLASTICS LIMITED
Model
MK/82/B/N/E32
Catalog number
MK82BNE32
Device description
Myringotomy Kit with Grommets
Published
2018-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JYPKnife, Myringotomy

Product Code Classifications

CodeDeviceSpecialtyClass
JYPKnife, MyringotomyEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060180251000PackageGS110In Commercial Distribution
05060180252953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060180251000050601802510005060180251000
05060180252953050601802529535060180252953

GMDN Terms

TermDefinition
Secretion suction kitA collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight.
Special Storage Condition, Specify00Store in a clean, dry environment, at room temperature. Avoid extremes of temperature and humidity.
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+441823351040sales@exmoorltd.com

Regulatory Flags

DUNS number
298725490
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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

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05060180250447EXMOORS1S12018-09-11
05060180250072EXMOORS1001/640S1001/6402018-09-14
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05060180250058EXMOORS1005/490S1005/4902018-09-14
05060180250232EXMOORS101S1012018-09-11
05060180250096EXMOORS1010/290S1010/2902018-09-14
05060180250027EXMOORS1010/340S1010/3402018-09-14
05060180250034EXMOORS1010/540S1010/5402018-09-14
05060180250089EXMOORS1011/300S1011/3002018-09-14
05060180250010EXMOORS1011/390S1011/3902018-09-14
05060180250003EXMOORS1012/300S1012/3002018-09-14
05060180250249EXMOORS102S1022018-09-11
05060180250256EXMOORS103S1032018-09-11
05060180250263EXMOORS104S1042018-09-11
05060180250270EXMOORS105S1052018-09-11
05060180250287EXMOORS106S1062018-09-11
05060180250294EXMOORS107S1072018-09-11
05060180250300EXMOORS108S1082018-09-11

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G586E7213780Novo SurgicalNOVO SURGICAL, INC.JYP2023-12-18
00840183515966BR Surgical, LLCBR Surgical, LLCJYP2023-04-03
00840183515973BR Surgical, LLCBR Surgical, LLCJYP2023-04-03
00842331167089Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-13
00842331148354Novo Surgical Inc. NOVO SURGICAL, INC.JYP2022-11-12
04046826103194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
04046826103200MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJYP2020-09-24
M633301705HH0JEDMEDJEDMED INSTRUMENT COMPANYJYP2020-09-01
M6333814000ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
M633S3814020ADEPT MEDICALJEDMED INSTRUMENT COMPANYJYP2020-09-01
04038653176366AESCULAPAesculap AGJYP2020-04-22
05060180254988EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
05060180255022EXMOOREXMOOR PLASTICS LIMITEDJYP2019-05-30
10381780082514Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
10381780084440Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYP2018-10-24
05060180250737EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
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05060180250751EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
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05060180250775EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250782EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180256357EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
05060180250928EXMOOREXMOOR PLASTICS LIMITEDJYP2018-10-11
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